Real life patterns of care and progression free survival in metastatic renal cell carcinoma patients: retrospective analysis of cross-sectional data

Abstract

BackgroundPatient characteristics and survival outcomes in randomized trials may be different from those in real-life clinical practice. The objective of this study was to describe treatment pathways, safety, drug costs and survival in patients with metastatic Renal Cell Carcinoma (mRCC) in a real world setting.MethodsA retrospective analysis was performed using IQVIA real world oncology cross-sectional survey data, a retrospective treatment database collecting anonymized patient-level data in Europe. Data on treatment naïve patients with mRCC who received a first-line targeted therapy in France were extracted for the period 2005–2015. Descriptive analyses were performed on treatment patterns, patient characteristics and safety profiles. Progression Free Survival (PFS) was determined using Kaplan-Meier survival analysis.ResultsOne thousand three hundred thirty-one patients with mRCC who received a first-line targeted therapy were included. The male/female sex ratio was 2.5 and 66% of patients were aged > 60 years. 83% of patients had clear cell adenocarcinoma. 83% of patients underwent a surgical procedure, 10% had radiotherapy. In patients who received a first-line targeted therapy, 73% received sunitinib. The mean time from diagnosis to first-line treatment by targeted therapies in patients initially diagnosed with metastatic disease was 3.3 months [95% CI:2.5–4.1]. In patients who received second-line targeted therapy n = 257 (19%), the most frequently observed treatment sequences were sunitinib-everolimus (33%) and sunitinib-sorafenib (27%). Adverse events data were available for 501 patients and adverse events were documented in 70% of patients, most frequently diarrhoea. The overall median PFS was 13 months [95% CI:11.5–16].ConclusionPatient characteristics were consistent with the literature. Treatment patterns appeared to follow current practice guidelines. Despite some variations, PFS in our study seems to be consistent with findings from other real world studies. Nevertheless, PFS results were higher than those observed in clinical trials. Due to the use of cross-sectional data, PFS in our study should be interpreted with caution.Electronic supplementary materialThe online version of this article (10.1186/s12885-018-4117-z) contains supplementary material, which is available to authorized users.

Real‐world progression, treatment, and survival outcomes during rapid adoption of immunotherapy for advanced non–small cell lung cancer

“…Cancer November 15, 2019 The stronger correlation between OS and rwTTD compared with OS and rwPFS differs from typical cytotoxic therapy findings. 20 This could reflect the practice of treatment beyond RECIST-defined progression, because OS and rwTTD capture the benefit of the additional immunotherapy exposure, but rwPFS does not; further research is ongoing.…”

“…The estimated median rwPFS in this cohort was similar to that observed in all pivotal PD‐(L)1 inhibitor trials, except for 1 trial that was restricted to patients without an EGFR mutation or ALK rearrangement. PFS concordance between real‐world patients and traditional clinical trial cohorts has also been observed before . rwPFS, an intermediate endpoint, may be linked more closely to treatment effect than to OS, because OS inherently captures the impact of all subsequent therapies administered to the patient after the PD‐(L)1 inhibitor‐containing regimen.…”

“…PFS concordance between real-world patients and traditional clinical trial cohorts has also been observed before. 19 rwPFS, an intermediate endpoint, may be linked more closely to treatment effect than to OS, because OS inherently captures the impact of all subsequent therapies administered to the patient after the PD-(L)1 inhibitorcontaining regimen.…”

“…In the subcohort of 1219 patients whose PD-L1 test report included a cell staining percentage (23%; n = 5257), median OS was 11.5, 8.8, and 8.0 months for those with ≥50%, from 1% to 49%, and <1% cell staining, respectively. In contrast, in the smaller (and not mutually exclusive) group Cancer November 15, 2019 of 862 patients whose report provided an interpretation of PD-L1 test results (16%; n = 5257), those with results classified as positive and negative had a median OS of 10.4 and 9 months, respectively. rwPFS differed by PD-L1 cell staining level (Fig.…”

“…Cancer November 15, 2019 This study expands our prior investigation of real-world patients with advNSCLC who received treatment with nivolumab or pembrolizumab (both PD-1 inhibitors), 4 conducted during the early adoption period after the initial approval in advNSCLC (both as the second or higher therapy line; nivolumab for patients with squamous histology tumors, and pembrolizumab for patients with PD-L1-expressing tumors). [5][6][7][8] Since that study, 1) 4 additional approvals in advNSCLC have been granted to 3 different anti-PD-(L)1 therapies; 2) the number of patients treated with PD-(L)1 inhibitors and the follow-up period have substantially increased; 3) scientific understanding of PD-L1 testing has matured; 4) management has changed, including the practice of treating beyond RECIST-defined progression based on the continued benefit observed in some cases after early "pseudoprogression" because of inflammatory response; and 5) recognition of the importance of progression and treatment-based intermediate endpoints for patients has grown.…”